CQV Supervisor: Cell Therapy Plant Compliance Lead

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company 1:

Eight weeks parental leave

Job summary

Legend Biotech is seeking a CQV Supervisor for the Facilities & Engineering team in Raritan, NJ to provide commissioning, qualification and validation support for the cGMP cell therapy manufacturing plant. This role will manage protocols, vendor relations, deviations and remediation to enable compliant production and release of personalized cell therapies.

The position requires a Bachelor’s in Science/Engineering and at least 7 years of relevant aseptic manufacturing experience, with strong

Qualifications

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 7 years relevant work experience is required.
• Strong interpersonal and written/oral communication skills.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.

Responsibilities

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable. acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Train and support the junior team members on different CQV activities.
• Present CQV work to regulatory and internal audit teams.
• Make decisions on technical approach, methodology per applicable procedure.
• Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.
• Other responsibilities as assigned.

Skills

Communication skills

Attention to detail

Leadership

Teamwork

Education

Bachelor's Degree in Science or Engineering

Tools

Microsoft Office

Job description

Legend Biotech is seeking a CQV Supervisor for the Facilities & Engineering team in Raritan, NJ to provide commissioning, qualification and validation support for the cGMP cell therapy manufacturing plant. This role will manage protocols, vendor relations, deviations and remediation to enable compliant production and release of personalized cell therapies.

The position requires a Bachelor’s in Science/Engineering and at least 7 years of relevant aseptic manufacturing experience, with strong